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Starting soon Observational

Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause

NCT05483634 · tracked via the Priya Life Science Taiwan tracker
Phase
Observational
Started
2025-12-01
Last updated
2025-05-09

Condition(s) studied

MenopausePlatelet-rich PlasmaEstrogen Replacement TherapyVaginal Atrophy

Investigational drug(s) / intervention(s)

Vaginal estrogen supplementPlatelet-rich plasma injection

Vaginal estrogen supplement: Daily vaginal estrogen supplement, then twice per week. Continue for three months.

Platelet-rich plasma injection: Monthly platelet-rich plasma injection for three months

Study summary

The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia.

The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. Observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used for evaluation of the effectiveness and side effects.

Eligibility

Sex
FEMALE
Min age
45 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Women with menopause * Patients with symptoms of genitourinary syndrome of menopause Exclusion Criteria: * Genitourinary bleeding or infection without definitive diagnosis * Coagulopathy * Allergy to medication or therapy related with the treatment * Chronic disease that might influence outcome * Using medication that might influence outcome in 30 days * Using hormone or steroid within 8 weeks

Primary outcome measure(s)

  • Visual analogue scale (VAS) — 2022/8/10-2024/2/28
    Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria
  • Vaginal health index score (VHIS) — 2022/8/10-2024/2/28
    One of the most commonly used scores for the evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration
  • Female Sexual Function Index (FSFI) — 2022/8/10-2024/2/28
    A brief multidimensional scale for assessing sexual function in women.

Trial sites (1)

FacilityCityRegionStatus
MacKay Memorial Hospital Taipei Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05483634 on ClinicalTrials.gov ↗ ← All trials in Taiwan